Determination and quantitation of sildenafil and its major metabolite in the breast milk of a lactating woman

Wollein, Uwe; Schech, Bernd; Hardt, Jochen; Schramek, Nicholas

doi:10.1016/j.jpba.2015.12.006

Cited by 13 publications

(10 citation statements)

References 21 publications

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“…It is unknown whether prostacyclin agents such as iloprost or epoprostenol are excreted into human milk, but due to the short plasma half‐life of these two agents, excretion should be limited. Sildenafil and its major metabolite are excreted in human breast milk, but the clinical effects to the newborn are not well described . Caution should be used when these agents are used concomitantly while breastfeeding, and the benefits and risks of breastfeeding should be discussed with the mother, with close monitoring of the infant for adverse effects.…”

Section: Discussionmentioning

confidence: 99%

“…Sildenafil and its major metabolite are excreted in human breast milk, but the clinical effects to the newborn are not well described. 24 Caution should be used when these agents are used e146 PHARMACOTHERAPY Volume 36, Number 9, 2016 concomitantly while breastfeeding, and the benefits and risks of breastfeeding should be discussed with the mother, with close monitoring of the infant for adverse effects.…”

Section: Discussionmentioning

confidence: 99%

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Inhaled Iloprost for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) During Pregnancy: A Case Report

et al. 2016

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Chronic thromboembolic pulmonary hypertension (CTEPH) is a subset of pulmonary hypertension caused by acute and recurrent pulmonary emboli. Pulmonary thromboendarterectomy is the treatment of choice, but 10-50% of patients are ineligible for this procedure. We describe the case of a 25-year-old, morbidly obese (228-kg, body mass index 83.5 kg/m(2) ) pregnant woman (G3 P2 ) who presented at 24 weeks' gestation; bilateral pulmonary angiography revealed filling defects and confirmed the diagnosis of CTEPH. The patient was evaluated and deemed to present too high of a risk for pulmonary thromboendarterectomy, so a multidisciplinary team initiated medical therapy. Sildenafil 20 mg orally 3 times/day was started at week 24 of gestation, and inhaled iloprost was added at 26 weeks and titrated to 5 µg inhaled every 2 hrs in order to optimize hemodynamic status prior to a cesarean section delivery scheduled to be performed 6 weeks later. At 32 weeks of gestation, the patient's pulmonary arterial systolic pressure was 77 mm Hg, right atrial pressure was 15 mm Hg, and pulmonary capillary wedge pressure of 16 mm Hg, and a healthy 1741-g male infant was delivered by cesarean section. The patient was transferred back to the medical intensive care unit in stable condition and discharged home 9 days following the procedure. Pharmacotherapeutic strategies for patients with CTEPH who become pregnant are limited to phosphodiesterase type 5 inhibitors and prostacyclin analog therapies due to the teratogenicity of the other drug classes used to treat the disorder (endothelin receptor antagonists and soluble guanylate cyclase stimulators). To our knowledge, this is the first case report of inhaled iloprost use in addition to oral sildenafil to improve patient symptomatology and hemodynamics during the peripartum period of a young pregnant patient with inoperable CTEPH. This drug therapy was used safely, with no noted adverse effects to the newborn or to the patient.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Inhaled Iloprost for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) During Pregnancy: A Case Report

et al. 2016

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“…Other electrochemical methods [12][13][14] were reported. Chromatographic determination of SDN in different matrices including human plasma, breast milk and other biological fluids were reported also [15][16][17][18]. The GC-MS/MS method quantified SDN together with five of its analogues in dietary supplements using capillary columns in twelve minutes.…”

Section: Mechanism Of Actionmentioning

confidence: 99%

Erectile Dysfunction and Premature Ejaculation Drugs: Mode of Action and Analytical Methods Literature Review

Ae¹,

Elhenawee²,

Saleh³

et al. 2021

J Drug Res Dev

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“…Therefore, the development of a sensitive and accurate analytical method for the simultaneous determination of PDE‐5 inhibitors is very crucial for screening of these drugs in complex matrices such as food and biological samples. There have been several reports in literature for the determination of different PDE‐5 inhibitors using HPLC , GC–MS or GC–MS/MS and LC–MS or LC–MS/MS . These methods have been used for the determinations of sildenafil, tadalafil and vardenafil in pharmaceuticals, biological samples such as hair, urine, plasma and breast milk, environmental samples (waste water and sewage sludge), beverage samples (energy drinks), herbal and dietary supplements.…”

Section: Introductionmentioning

confidence: 99%

Accurate and sensitive determination of sildenafil, tadalafil, vardenafil, and avanafil in illicit erectile dysfunction medications and human urine by LC with quadrupole‐TOF‐MS/MS and their behaviors in simulated gastric conditions

Özbek

Bakırdere

2018

J of Separation Science

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The widespread use of phosphodiesterase‐5 inhibitors has attracted broad attention of counterfeiters to develop illicit erectile products with inaccurate amounts, unknown toxicity, and purity of active ingredients. Correspondingly, intake of these products endangers consumer health and needs to be screened for precautionary actions to reduce this risk. Therefore, in this study, a sensitive and rapid analytical method has been developed for simultaneous determination of selected phosphodiesterase‐5 inhibitors present in illicit erectile medications and human urine. Quantification of the analytes was performed by liquid chromatography coupled with quadrupole‐time‐of‐flight tandem mass spectrometry system. The chromatographic separation was successfully achieved with a run period of 8 min. Low detection limits were obtained in the range of 1.63–9.81 ng/g with relative standard deviations below 7.72% obtained using the replicate measurements of lowest concentration in calibration plots. The analytical performance of the proposed method proved good linearity, low detection limits, good accuracy and precision with high percent recoveries for human urine samples. Developed method was successfully applied to real samples including four different brands of illicit erectile medications. The results obtained revealed the presence of high levels of sildenafil in analyzed samples. The behaviors of selected phosphodiesterase‐5 inhibitors were also studied in simulated gastric conditions.

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Determination and quantitation of sildenafil and its major metabolite in the breast milk of a lactating woman

Cited by 13 publications

References 21 publications

Inhaled Iloprost for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) During Pregnancy: A Case Report

Inhaled Iloprost for Chronic Thromboembolic Pulmonary Hypertension (CTEPH) During Pregnancy: A Case Report

Erectile Dysfunction and Premature Ejaculation Drugs: Mode of Action and Analytical Methods Literature Review

Accurate and sensitive determination of sildenafil, tadalafil, vardenafil, and avanafil in illicit erectile dysfunction medications and human urine by LC with quadrupole‐TOF‐MS/MS and their behaviors in simulated gastric conditions

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